Regeneron won FDA approval for Otarmeni (lunsotogene parvec), an AAV-mediated gene therapy for a rare inherited form of hearing loss caused by otoferlin variants. The decision makes the therapy the first gene treatment cleared under the FDA’s “national priority voucher” program, with Regeneron planning to offer Otarmeni at no cost to eligible US patients. The approval matters both clinically and commercially: the national priority voucher attached to the regulatory milestone can be monetized, providing a potential funding lever tied to development of future assets. Regeneron emphasized the clinical intent with an access-focused offering plan. The FDA’s action also reinforces how the voucher program is shaping gene-therapy development incentives, linking review pathways to downstream financial flexibility while still requiring evidence for safety and efficacy.